(93 days)
No
The description focuses on data trending, storage, and recall, with no mention of AI or ML algorithms for analysis or prediction.
No
The device provides a monitoring function only and has no direct interaction with the ventilator function, therefore it is not a therapeutic device.
No
The device description states, "It provides a monitoring function only and therefore has no direct interaction with ventilator function." Diagnostic devices typically analyze data to identify diseases or conditions, which is not the stated purpose of this monitoring-only device.
No
The device description explicitly states that the "Trending Option is a software and hardware modification" and "requires both software and hardware upgrades." It details the hardware upgrade as a "print circuit board with battery backed up 256K RAM."
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the product provides a "monitoring function only" and has "no direct interaction with ventilator function." It focuses on tracking and displaying parameters related to the ventilator and patient, as well as storing and recalling waveforms and loops. This is a monitoring and data management function, not a diagnostic test performed on biological samples.
- Device Description: The device is described as a software and hardware modification to a ventilator, adding features for trending, data storage, and waveform recall. This aligns with a monitoring and data management system for a medical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
The device's function is to monitor and manage data generated by a ventilator, which is a life support device. While the data it displays might be used by a clinician to inform diagnostic decisions, the device itself is not performing an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
This product is to be used only in conjunction with the Adult Star Model ventilator. It provides a monitoring function only and therefore has no direct interaction with ventilator function. The Trending option will periodically sample ventilator data to be used as trended parameters. This option is intended for the operator to track a total of 54 patient and ventilator parameters over a maximum time period of 72 hours. Three trended parameters can be displayed simultaneously. A cursor can then be used scan the trended dated to determine the time and magnitude of a particular occurrence or change in a monitored function. In addition, Patient data such as name, weight, clinician identification, and blood gas test data can be manually inputted. The Trending option allows real-time pressure, flow, and volume waveforms to be saved and recalled for comparison to subsequent waveforms. Pressure/Volume and Flow/Volume loops can also be saved and recalled for subsequent comparisons. A hardcopy print out can be made of all saved and trended data.
Product codes
Not Found
Device Description
Trending Option is a software and hardware modification to the Adult Star Ventilator (K872466). It adds three features: 72 hour trending of ventilator and patient monitored parameters, storage of Patient Data, and Save and Recall of real time waveforms. This option requires both software and hardware upgrades. The software, or firmware, is retained in EPROM's. The hardware upgrade consists of a print circuit board with battery backed up 256K RAM. A label is added to the front of the ventilator indicating that this option has been installed. This option is designed to function with all available options for the Adult Star Ventilator.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adult
Intended User / Care Setting
operator
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following environmental test were conducted on the Adult Star Ventilator with the Trending Hardware installed.
- Powerline Conducted Emissions: Passed
- Radiated Emission Measurements: Passed
- Radiated E-Field Susceptibility: Passed
- Electrostatic Discharge Susceptibility: Passed
- AC Voltage Fluctuation: Passed
- AC Voltage Dropout: Passed
- Slow Sag and Surges: Passed
- Fast Transient Burst: Passed
- Fast Surges: Passed
- Magnetic Fields Emissions: Passed
- Conducted Electromagnetic Energy: Passed
- Magnetic Field Immunity: Passed
- Quasi-Static Electromagnetic Field: Passed
- Sinusoidal Vibration: Passed
- Random Vibration: Passed
- Shock: Passed
- High temperature: Passed
- Low Temperature: Passed
- Humidity: Passed
System Level Tests:
- Design Validation for the Trending Option: Validates that the Design and Performance Specification has been correctly implemented.
- Design Validation of Options Selection: Verifies that all available options for the Adult Star can be correctly selected.
- Generic Testing (Includes specific testing for all available options: A regression level to verify that function of the basic ventilator and available options still perform as required with the Trending Option Installed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
K872466, K911804, K954724, K943106, K905272, K922654
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).
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510(k) Summary
Submitter's Name: Nellcor Puritan Bennett Inc.
- Address: 4280 Hacienda Drive Pleasanton, CA 94588
- (619) 450-9898 Phone:
- Contact Name: Albert Paul
- Date of Summary: October 31, 1996
- Trade Name: Trending Option for the Infrasonics Adult Star Ventilator
- Common Name: Adult Ventilator
- Continuous Ventilator (21 CFR 868.5895) Classification: Class II
- Predicate Device: Puritan Bennett Graphics 2.0 option for the Puritan-Bennett 7200 ae ventilator Bird Products Corp. Graphic Monitor
Trending Option is a software and hardware Description of Device: modification to the Adult Star Ventilator (K872466). It adds three features: 72 hour trending of ventilator and patient monitored parameters, storage of Patient Data, and Save and Recall of real time waveforms. This option requires both software and hardware upgrades. The software, or firmware, is retained in EPROM's. The hardware upgrade consists of a print circuit board with battery backed up 256K RAM. A label is added to the front of the ventilator indicating that this option has been installed. This option is designed to function with all available options for the Adult Star Ventilator.
Intended Use: This product is to be used only in conjunction with the Adult Star Model ventilator. It provides a monitoring function only and therefore has no direct interaction with ventilator function. The Trending option will periodically sample ventilator data to be used as trended parameters. This option is intended for the operator to track a total of 54 patient and ventilator parameters over a maximum time period of 72 hours. Three trended parameters can be displayed simultaneously. A cursor can then be used scan the trended dated to determine the time and magnitude of a particular occurrence or change in a monitored function. In addition, Patient data such as name, weight, clinician
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1
identification, and blood gas test data can be manually inputted. The Trending option allows real-time pressure, flow, and volume waveforms to be saved and recalled for comparison to subsequent waveforms. Pressure/Volume and Flow/Volume loops can also be saved and recalled for subsequent comparisons. A hardcopy print out can be made of all saved and trended data.
Statement of Similarities and/or Differences With Marketed Devices:
The Infrasonics Trending option is a software and hardware upgrade to the Infrasonics Adult Star ventilator. The graphical display of trended parameters are shown on the existing Adult Star CRT. The Trending option is similar to the Puritan Bennett Graphics 2.0 option and the Bird Products Graphics Monitor. The Puritan Bennett Graphics 2.0 option requires a 7200 ae ventilator and an optional 7202 Display. The Bird Graphics monitor is an optional display for the Bird infant and adult ventilators. The Puritan Bennett and the Bird Graphics monitor acquire and display data in a similar manner as the Infrasonics Trending option. All designs use the same general principles and incorporate similar technologies, materials, energy sources, and components.
The primary function of all three products is to acquire ventilator data through an electronic means and store that data for later retrieval. The technological characteristics of the devices are the same and raise no new questions of safety and effectiveness. It is concluded that the Trending Option is substantially equivalent to the Puritan-Bennett and Bird products.
Functionality with Available Options
The Trending Option for the Adult Star Ventilator is to be used in conjunction with or without other available options. The following is a list of the options and the 510(k) number associated with them:
| Product or Option to the Adult Star | Model Number |
|---|---|
| Adult Star Ventilator | K872466 |
| Pressure Control | K911804 |
| Flow Triggering | K954724 |
| Remote Alarm | K943106 |
| Lung Mechanics | K905272 |
| Pediatric and Compliance Compensations | K922654 |
It is possible, for example, for a ventilator to be configured with Trending and Pressure Control, or Trending, Pressure Control, and Flow Triggering. System testing was conducted to show the There is no limitation on the combinations that are available. The Trending option is independent of the other options.
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Summary of Testing:
The following environmental test were conducted on the Adult Star Ventilator with the Trending Hardware installed.
| Test Description | Results |
|---|---|
| Powerline Conducted Emissions | Passed |
| Radiated Emission Measurements | Passed |
| Radiated E-Field Susceptibility | Passed |
| Electrostatic Discharge Susceptibility | Passed |
| AC Voltage Fluctuation | Passed |
| AC Voltage Dropout | Passed |
| Slow Sag and Surges | Passed |
| Fast Transient Burst | Passed |
| Fast Surges | Passed |
| Magnetic Fields Emissions | Passed |
| Conducted Electromagnetic Energy | Passed |
| Magnetic Field Immunity | Passed |
| Quasi-Static Electromagnetic Field | Passed |
| Sinusoidal Vibration | Passed |
| Random Vibration | Passed |
| Shock | Passed |
| High temperature | Passed |
| Low Temperature | Passed |
| Humidity | Passed |
System Level Tests
The following system level tests were performed to validation the design of this option: . •
| Test | Description |
|---|---|
| Design Validation for the Trending Option | Validates that the Design and |
| Performance Specification has been | |
| correctly implemented. | |
| Design Validation of Options Selection | Verifies that all available options for |
| the Adult Star can be correctly | |
| selected. | |
| Generic Testing (Includes specific | |
| testing for all available options: | A regression level to verify that |
| function of the basic ventilator and | |
| available options still perform as | |
| required with the Trending Option | |
| Installed. |